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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 06/22/2021
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the freestyle libre sensor.Customer received a "scan again in 10" message for more than two hours and was unable to obtain readings.As a result, customer experienced cramping, a seizure, and loss of consciousness and was unable to self-treat, requiring treatment of baqsimi 3mg nasal powder.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the freestyle libre sensor.Customer received a "scan again in 10" message for more than two hours and was unable to obtain readings.As a result, customer experienced cramping, a seizure, and loss of consciousness and was unable to self-treat, requiring treatment of baqsimi 3mg nasal powder.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the freestyle libre sensor.Customer received a "scan again in 10" message for more than two hours and was unable to obtain readings.As a result, customer experienced cramping, a seizure, and loss of consciousness and was unable to self-treat, requiring treatment of baqsimi 3mg nasal powder.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key12131418
MDR Text Key260356948
Report Number2954323-2021-74850
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2022
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/07/2021
Supplement Dates Manufacturer Received07/07/2021
09/28/2021
Supplement Dates FDA Received07/08/2021
10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight61
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